dose evaluation of mk-1966 in combination with sd-101 in participants with advanced malignancies (mk-1966-001)

Conditions: Neoplasms, Advanced

Summary: this was a non-randomized, open-label study of mk-1966 used in combination with sd-101 in the treatment of advanced malignancies. the study included an initial dose evaluation phase (part a) to determine the maximum tolerated dose (mtd)/maximum administered dose (mad) by evaluating dose limiting toxicities (dlts) of four dose combinations of mk-1966 and sd-101. following determination of the mtd/mad, approximately 20 participants each were to be enrolled in two expansion cohorts (parts b or c) to confirm/refine the mtd/mad. the study was terminated by the sponsor before enrollment into part a concluded and before enrollment into parts b and c began.


Eligibility criteria:
inclusion criteria: * has a histologically- or cytologically-confirmed advanced malignancy that has progressed after standard-of-care therapy/treatments and there is no available therapy likely to convey clinical benefit * has an eastern cooperative oncology group (ecog) performance status of 0 or 1 * has a life expectancy ≥ 6 months * female participants must not be pregnant (negative urine or serum human chorionic gonadotropin test at screening and again within 72 hours prior to receiving the first dose of study therapy) * female and male participants of reproductive potential must agree to use adequate contraception during the course of the study through 120 days after study the last dose of study therapy * has ability to submit archived or fresh tumor sample during the screening period exclusion criteria: * has had chemotherapy, radiation, or biological cancer therapy within 4 weeks prior to the first dose of study therapy, or who has not recovered to common terminology criteria for adverse events (ctcae) grade 1 or better from the adverse events due to cancer therapeutics administered more than 4 weeks earlier * has participated in a study of an investigational agent and received study therapy or used an investigational device within 28 days of study start * is expected to require any other form of antineoplastic therapy while on study * is on chronic systemic steroid therapy in excess of replacement doses, or on any other form of immunosuppressive medication * has a history of a malignancy, unless potentially curative treatment has been completed, with no evidence of malignancy for 5 years * has known active central nervous system (cns) metastases and/or carcinomatous meningitis * has had a severe hypersensitivity reaction to treatment with another monoclonal antibody * has an active autoimmune disease that has required systemic treatment in past 2 years * has an active infection requiring therapy * has active, current pneumonitis, or a history of (non-infectious) pneumonitis that required steroids * has had a prior stem cell or bone marrow transplant * is positive for human immunodeficiency virus (hiv) and/or hepatitis b or c * has known psychiatric disorder that would interfere with fulfilling the requirements of the study * is a regular user of any illicit drugs or had a recent history of substance abuse * has symptomatic ascites or pleural effusion * is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study * has clinically significant heart disease that affects normal activities * has had major surgery (requiring at least a 3 day hospital stay) in the past 28 days * has received a live vaccine within 30 days prior to first dose of study therapy